KETOCONAZOLE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)

Tersedia dari:

Direct Rx

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. Drug Interactions Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with ketoconazole tablets. Coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to s

Ringkasan produk:

debossed "A" over "35" on one side and plain with bisect on the other side. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. Manufactured by: Aavis Pharmaceuticals, Hoschton, GA 30548 Manufactured for: Burel Pharmaceuticals, Inc. Richland, MS 39218 Code. L7020/00 Rev. 02/2020

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

KETOCONAZOLE- KETOCONAZOLE TABLET
Direct Rx
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Ketoconazole
(KEE-toe-KON-a-zole)
Tablets USP, 200 mg
What is the most important information I should know about
ketoconazole tablets USP?
Ketoconazole tablets is not the only medicine available to treat
fungal infections and should only be used
when other medicines are not right for you. Talk to your healthcare
provider to find out if ketoconazole
tablets are right for you.
Ketoconazole tablets USP can cause serious side effects, including:
liver problems (hepatotoxicity). Some people who were treated with
ketoconazole the active ingredient in
ketoconazole tablets, had serious liver problems that led to death or
the need for a liver transplant. Call
your healthcare provider right away if you have any of the following
symptoms:
loss of appetite or start losing weight (anorexia)
nausea or vomiting
feel tired
stomach pain or tenderness
dark urine or light colored stools
yellowing of your skin or the whites of your eyes
fever or rash
changes in the electrical activity of your heart called QT
prolongation. QT prolongation can cause
irregular heart beats that can be life threatening. This can happen
when ketoconazole tablets are taken
with certain medicines, such as dofetilide, quinidine, pimozide,
cisapride, methadone, disopyramide,
dronedarone, and ranolazine. Talk to your healthcare provider about
other medicines you are taking
before you start taking ketoconazole tablets. Tell your healthcare
provider right away if you feel faint,
lightheaded, dizzy, or feel your heart beating irregularly or fast.
These may be symptoms related to QT
prolongation.
What are ketoconazole tablets USP?
Ketoconazole tablets are prescription medicine used to treat serious
fungal infections including:
blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and
paracoccidioidomycosis.
Ketoconazole tablets are not for people with fungal nail infections.
Ketoconazole tablets have not been approved for the treatment of
advanced prostate cancer or Cushing's
syndrome. The safety a

Karakteristik produk

KETOCONAZOLE- KETOCONAZOLE TABLET
DIRECT RX
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KETOCONAZOLE
WARNING
Because ketoconazole tablets have been associated with serious adverse
reactions
(see WARNINGS section), ketoconazole tablets are not indicated for
treatment of
onychomycosis, cutaneous dermatophyte infections, or Candida
infections.
Ketoconazole tablets should be used only when other effective
antifungal therapy is
not available or tolerated and the potential benefits are considered
to outweigh the
potential risks.
Hepatotoxicity
Serious hepatotoxicity, including cases with a fatal outcome or
requiring liver
transplantation has occurred with the use of oral ketoconazole. Some
patients had
no obvious risk factors for liver disease. Patients receiving this
drug should be
informed by the physician of the risk and should be closely monitored.
See
WARNINGS section.
QT Prolongation and Drug Interactions Leading to QT Prolongation
Co-administration of the following drugs with ketoconazole is
contraindicated:
dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide,
dronedarone,
ranolazine. Ketoconazole can cause elevated plasma concentrations of
these drugs
and may prolong QT intervals, sometimes resulting in life-threatening
ventricular
dysrhythmias such as torsades de pointes. See CONTRAINDICATIONS,
WARNINGS, and PRECAUTIONS: DRUG INTERACTIONS sections.
Ketoconazole tablets, USP is a synthetic broad-spectrum antifungal
agent available in
scored white tablets, each containing 200 mg ketoconazole base for
oral administration.
Inactive ingredients are colloidal silicon dioxide, croscarmellose
sodium, magnesium
stearate and methylcellulose. Ketoconazole is
cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-
2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl]
piperazine and has the
following structural formula:
Ketoconazole is a white to slightly beige, odorless powder, soluble in
acids, with a
molecular weight of 531.44g/mol.
Pharmacokinetics
Absorption
Ketoconazole is a weak dibasic agent and thus requires acidity for
dissolution a